Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns

Condition(s) studied

Investigational drug(s) / intervention(s)

AI-based Apps: Families which will use the digital interactive tools to empower parents in their daily dietary choices.

Mediterranean-based diet toolkit and activities: Families which will receive educational materials and adolescents will perform educational activities.

Healthy plant-based snacks: Families in which children will include the snacks in their diet.

AI-based Apps + Mediterranean-based diet toolkit and activities: Families which will use the digital interactive tools and receive educational material, and adolescents will perform educational activities.

AI-based Apps + Healthy plant-based snacks: Families which will use the digital interactive tools and children will include the snacks in their diet.

Mediterranean-based diet toolkit and activities + Healthy plant-based snacks: Families which will receive educational material, adolescents will perform educational activities, and children will include the snacks in their diet.

AI-based Apps + Mediterranean-based diet toolkit and activities + Healthy plant-based snacks: Families which will use the digital interactive tools and will receive educational material, children will include the snacks in their diet, and adolescents will perform educational activities.

Study summary

The population from Mediterranean countries is abandoning the Mediterranean diet (MD) traditional dietary and lifestyle pattern moving to unhealthier habits because of profound cultural and socio-economic driven lifestyle changes. Families, particularly parents, are responsible for structuring children's early experiences with food and eating as well as for transmitting knowledge of the MD. Educational family approaches can not only lead to more solid food literacy and healthy habits for children in the family but can also improve dietary profiles for adults, thus preventing future health-related problems. There is a lack of adequate study protocol for inducing a positive dietary, environmental and lifestyle behaviour in the family setting. SWITCHtoHEALTHY study aims to evaluate the effects of a multi-component nutritional intervention deployed at family level on the adherence to the MD pattern in families from three Mediterranean countries.

A parallel, randomized, single blind controlled multicentric nutritional intervention study will be conducted in 480 families with children and adolescents among 3-17 years from Spain, Morocco, and Turkey over 13 months. Specifically, 160 families per country will be enrolled in a multi-component intervention and allocated to use digital interactive tools, hands-on educational materials and activities for adolescents, easy-to-eat healthy plant-based snacks for children, or a combination of two or three of the components. There will also be a control group that will receive general advice on healthy eating. The intervention study is scheduled to begin in November 2023.

Through the digital tools the parents will use an interactive App through which they will receive personalized weekly meal plans while the engagement of all the family will be prompted by using a life simulation game. A set of activities for adolescents based on a learning-through-play approach to be carried out within the family and at school will be developed by adolescents and voluntary schoolteachers through co-creation sessions. The innovative and sustainable plant-based snacks will be produced by local food companies and introduced in the children dietary plan as healthy alternatives for between meals. By using a full-factorial design, the independent and combined effects of each intervention component will be tested by comparing the 7 intervention groups with the control group.

Eligibility

Primary outcome measure(s)

• Change in adherence to the Mediterranean Diet — Phase 2 (month 10 to month 13)
  The main outcome will be adherence to the MD measured through MEDAS questionnaire score in parents. The effectiveness of the multi-component intervention will be evaluated by comparing the MEDAS score between the control and intervention groups during the intervention period (Phase 2). The MEDAS score is an extension of a 9-point score developed in the Prevention with Mediterranean Diet (PREDIMED) trial. A score of 14 points means maximum adherence to the Mediterranean Diet while a score below 7 points means low adherence.
• Change in adherence to the Mediterranean Diet — Phase 2 (month 10 to month 13)
  The main outcome will be adherence to the MD measured through KIDMED questionnaire score in children. The effectiveness of the multi-component intervention will be evaluated by comparing the KIDMED score between the control and intervention groups during the intervention period (Phase 2). The KIDMED score ranges from 0 to 12 points, so a score greater than or equal to 8 points means optimal Mediterranean Diet adherence while a score below or equal to 3 points means very low-quality diet, and between 4 and 7 points means that need to improve the eating pattern to fit the Mediterranean pattern.

Trial sites (1)

More Fundació Eurecat trials in Spain

Other trials for the same condition